Payroll Analyst

Staff Software Engineer

Customer Quality Engineer

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Representative - SAP

Operation Supervisor

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Responsibilities:&nbsp; <ul><li>Provide effective and efficient on-site Payroll service ,contribute in company Philippine payroll and related programs (eg. tax, insurance, labor cost report, benefit programs) processing within established budgets, principles and regulations, laws and employment standards , manage the accurate and timely processing of payroll related activities.&nbsp;</li><li>Work with plant operations and T&amp;A colleague to ensure time &amp; attendance data smoothly flow into payroll process and ensure payroll accuracy&nbsp;</li><li>Responsible to employee’s query about payroll&nbsp;</li><li>Responsible to payroll related files documentation and ensure meet audit requirement&nbsp;</li><li>Act as advisor to business on country policies, local regulations and company policies, keep abreast of all Payroll regulatory related issues, foresee potential risk vs current practice and raise for discussion, drive for risk elimination to ensure compliance&nbsp;</li><li>Support HRBP to develop site pay policy/procedures</li><li>Responsible for audits and ensure accuracy and data integrity, implement related action plan as audit needs&nbsp;</li><li>Continuously review and enhance payroll processes/programs and implement improvement, manage global or regional payroll integration or harmonization program, promote global or regional payroll system at site and ensure the adoption rate .</li><li>Provide on-site HR services operations assigned by manager.</li></ul> Requirements: <ul><li>Bachelor’s degree, human resources education or equivalent&nbsp;</li><li>7 years progressive payroll experience as independent Payroll Analyst&nbsp;</li><li>Familiarity with PH agencies such as SSS, PhilHealth, and Pag-ibig, as well as tax regulations (BIR).</li><li>Working experience in international enterprise&nbsp;</li><li>Good knowledge of country and local Payroll laws&nbsp;</li><li>Breadth of experience in Payroll disciplines, including data management, metrics and measurement&nbsp;</li><li>Proficient in MS Office (incl. Word, Excel and PowerPoint)&nbsp;</li><li>Experience with tax systems and reporting&nbsp;</li><li>Good service mindset and collaboration spirit&nbsp;</li><li>Experience with time and attendance systems preferred</li></ul>

Responsibilities: <ul><li>Develop software portable to a wide variety of project applications and platforms through the entire software lifecycle.&nbsp;</li><li>Perform technical analysis of candidate software, firmware, and hardware systems.&nbsp;</li><li>Develop test plans, test frameworks and unit tests.&nbsp;</li><li>Lead the project interface between business teams and technical teams to translate business requirements into technical solutions.&nbsp;</li><li>Collaborate effectively with other project team members to develop new concepts and projects.</li></ul> Requirements: <ul><li>Engineering degree in Computer Science, Electrical/Electronics/ Communication Engineering or related subject is required (2:1 or higher).&nbsp;</li><li>Proficiency in multiple relevant programming languages (E.g. C/C++/Python) is required.&nbsp;</li><li>Proficiency in utilizing devops tools such as Github or Gitlab is required.&nbsp;</li><li>Competency with embedded Linux (e.g. Buildroot or Yocto) is required.&nbsp;</li><li>Competency with bare metal development for microcontroller families such as STM32 or Nordic nRF is required.&nbsp;</li><li>Competency in an IoT protocol such as MQTT or CoAP, is required.&nbsp;</li><li>Demonstrable awareness and participation in other engineering disciplines such as electronics or mechanical engineering is preferred.&nbsp;</li><li>Experience with embedded RTOS (e.g. FreeRTOS or Zephyr) is preferred.&nbsp;</li><li>Knowledge of AI and machine learning concepts and algorithms is preferred.&nbsp;</li><li>Familiarity with cloud platforms such as AWS, in particular elements related to IoT service deployment is preferred.&nbsp;</li></ul> Critical Experience: <ul><li>8+ years relevant experience in embedded software development.&nbsp;</li><li>Demonstrable track record in leading the software element of complex projects.&nbsp;</li><li>Strong communication skills for collaborating with project team members, customers, internal business and technology leaders.&nbsp;</li><li>Proven ability to execute engineering deliverables.&nbsp;</li><li>Self-starter able to work independently and multitask with strong project planning skills.</li></ul>

Responsibilities: <ul><li>Quality point of contact for assigned Southeast Asia customer accounts.</li><li>Provide the Voice of the Customer feedback to product management, product engineering and manufacturing locations for characteristics that can become quality or application risks to the customer.</li><li>Manages Quality / Reliability interactions with the customer, including regular communication and escalations.&nbsp;</li><li>Provides technical support in evaluating products from a quality and reliability standpoint.</li><li>Leads cross-functional problem-solving teams to investigate quality issues and minimize customer impact, Company PPM, cost of poor quality and drive timely resolution.</li><li>nfluences without authority in efforts to achieve 5D/8D response time within 10 business days or less.&nbsp;</li><li>Responsible for coordinating and ensuring completion of customer quality requested activities across design and manufacturing. This includes coordinating globally for all sites, factories, and associated teams within company.&nbsp;</li><li>Carries out the customer quality improvement strategy.</li><li>Ensures compliance to company quality policies and procedures related to customer requirements.</li><li>Partners closely with sales, engineering, and operations to ensure organizational alignment regarding setting targets and achieving quality objectives for our customers.</li><li>Partners with engineering and sales to establish trust with our customers by sharing our DND strategic quality roadmap as well as resolving problems in a timely manner.</li><li>Regularly conducts reviews with key customers regarding DNDs quality &amp; delivery performance.</li><li>Drives systemic corrective action and continual improvement for customers through training and implementation and use an array of quality improvement tools.</li><li>Regularly reports to management on the overall performance and effectiveness of the assigned strategic customer account.</li><li>Manage quality issues or inquiries for parts in assigned Global Product Lines. The parts may be made at a company facility or at a sub-tier supplier.&nbsp;</li><li>Supports the MRB team functions for disposition of non-conforming products.</li><li>Visit local customers and travel within Southeast Asia to customer locations to review company product and application as it is being used by the customer and to foster productive working relationships.</li><li>Conduct audits at manufacturing sites and attend to customer audits.&nbsp;</li><li>Work with DC, Planner, Sales &amp; CCP on block stock &amp; RMA return.</li><li>Coordinate onsite sorting at customer site with Sales, Planner &amp; CCP.</li><li>Coordinate RMA request &amp; return with manufacturing.</li></ul> Requirements: <ul><li>Bachelor Degree in Engineering with technical focus.</li><li>5+ years minimum quality assurance experience working in a global capacity.</li><li>Preferred customer quality experience in the electronics industry.</li><li>Demonstrated ability to lead teams, forge strong internal relationships, and drive transformation globally.</li><li>Knowledge and application of quality system regulations (ISO 9000, 14000 and 18000).</li><li>Experienced in the use of Lean, Six Sigma, Kaizen, 8D and other advanced statistical methods including Design of Experiments (DOE), Statistical Process Control (SPC), and Process Capability (CpK) techniques.</li><li>Possesses strong leadership skills and executive level presence.</li><li>Self-motivated, efficient, ability to work with little or no supervision, and committed to a team approach.</li><li>Strong interpersonal, organization, and project management skills.</li><li>Ability to prioritize responsibilities in a fast-paced work environment.</li><li>May require travel to customers and other company locations, including overnight and multi-day trips.</li><li>Experience in core processes such as stamping, molding, plating and assembly preferred.</li></ul>

Responsibilities: Trade Compliance Activities in the BU: <ul><li>Execute trade operations and provide compliance oversight for the assigned BU to ensure compliance with import/export laws and regulations in UK, US &amp; Indian SCOMET Export Controls</li><li>Maintain trade operations and compliance activities in accordance with policies, procedures, and controls, in collaboration with&nbsp;</li></ul> key stakeholders throughout the BU: <ul><li>Act as a point of contact for BU stakeholders on trade-related matters.</li><li>Work with BU stakeholders and counsel to understand business changes and develop trade-related solutions/strategies and controls to ensure compliance</li><li>Maintain BU-level Key Performance Indicators (KPIs) and reporting to ensure efficiency and effectiveness of the operations</li><li>Partner with Trade Compliance Professionals and Stakeholders across the Enterprise</li><li>Partner with GTS Governance to monitor trade compliance regulatory and legislative changes, assess the potential impact to the BU, and determine the necessary actions and communications to the appropriate stakeholders</li><li>Work with GTS Governance teams to conduct trade compliance audits and oversee corrective action plans</li><li>Partner with GTS Governance to develop and administer effective trade compliance training as required throughout the region and organization&nbsp;</li><li>Ensure appropriate utilization of the GTS Operations Service Centre for product classification (import and export), restricted party screening, and duty savings compliance, and otherwise ensure proper country of origin determination, valuation, and admissibility</li><li>Work with the Operational Service Centres to identify, evaluate and administer opportunities to facilitate trade in a cost-effective and compliant manner (e.g. make use of applicable Free Trade Agreements, Duty Drawback, First Sale for Export, Foreign Trade Zones, etc.)&nbsp;</li><li>Establish and maintain relationships with internal functions, including corporate functions, to encourage awareness of global trade compliance issues, pro-actively identify trade risk and threats, and develop appropriate trade compliance controls</li></ul> Talent Development &amp; Leadership: <ul><li>Create a culture of engagement and performance in alignment with core values&nbsp;</li><li>Lead by example and act with empathy</li></ul> Requirements: <ul><li>Experience in UK, US &amp; Indian SCOMET Export Controls</li><li>SAP &amp; GTS experience</li><li>Customs Compliance experience</li><li>Management of a team</li><li>Success in the role requires strong analytical and creative problem-solving skills, highly developed oral and written communication skills, and the ability to work with interdisciplinary teams (internal and external) to drive issues and projects to conclusion.&nbsp;&nbsp;</li></ul> In addition, successful candidate will have the following qualifications, experience, and skills: <ul><li>Bachelors degree required (international business, supply chain, law, or related field)</li><li>3+ years’ experience in global trade compliance</li><li>Functional knowledge of import and export regulations and familiarity with customs practices in countries across the region</li><li>Proven ability to work with variety of business groups, including supply chain, legal, procurement and finance</li><li>Ability to foster teamwork and internal and external relationships</li><li>Excellent organizational habits and priority management&nbsp;</li><li>Customer focused with a commitment to quality</li><li>Travel may be necessary in fulfillment of responsibilities</li></ul>

Responsibilities: Strategic Leadership and Team Development:&nbsp; <ul><li>Lead, mentor, and manage a team of up to 5-8 Analysts, Specialists, and Associate Managers.&nbsp;</li><li>Build a culture of high performance, ensuring team engagement, development, and retention to meet organizational goals.</li></ul> Customer and Stakeholder Collaboration:&nbsp; <ul><li>Serve as a strategic partner for key internal and external stakeholders, including Sales, Supply Chain, and Distribution leaders, to resolve escalated customer service issues and deliver seamless order-to-delivery (OTD) solutions.</li></ul> Operational Excellence and Process Improvement:&nbsp; <ul><li>Drive initiatives that enhance efficiency and reduce costs across customer service operations.&nbsp;</li><li>Implement continuous improvement strategies using methodologies like Six Sigma or LEAN while ensuring compliance with organizational policies, including GAAP and SOX requirements.</li></ul> Data-Driven Decision Making:&nbsp; <ul><li>Analyze KPIs, SLAs, and service metrics to identify trends, assess performance, and develop strategies to optimize customer service and supply chain operations.</li></ul> Strategic Planning and Execution:&nbsp; <ul><li>Collaborate with senior leadership to design and execute strategic customer service plans aligned with Kellanova’s broader business objectives.&nbsp;</li><li>Partner with third-party service providers to promote operational effectiveness and supply chain efficiency.</li></ul> Requirements:﻿﻿ <ul><li>Bachelor’s degree required, with at least two-three years of experience in customer service, supply chain, or a related field.</li><li>Prior experience in a leadership role is essential.</li><li>Strong track record of managing and developing high-performing teams, fostering a culture of accountability, and driving employee engagement.</li><li>Advanced proficiency in ERP systems (e.g., SAP) and Microsoft Office, with a solid understanding of order-to-delivery and supply chain operations.</li><li>Ability to analyze complex data, identify trends, and develop innovative, data-driven solutions to address customer service challenges and improve processes.</li><li>Exceptional verbal and written communication skills in English, with experience working effectively across functions, regions and presenting to senior leadership.</li><li>Expertise in implementing continuous improvement initiatives using Six Sigma, LEAN, or similar methodologies to achieve operational efficiencies and cost reductions.</li><li>Strong organizational skills with the ability to prioritize and manage multiple initiatives, consistently meeting deadlines and exceeding performance objectives.</li></ul>

Role Description: <ul><li>Customer Service Teams interact with customers, company sales and/or service representatives to handle a variety of pre-sales or post-sales service functions.</li><li>They take and process transactions via phone, internet and correspondence from customers and representatives and respond to inquiries about products or services.</li><li>They may promote and sell our companys products or services as well as investigate and resolve customer complaints.</li><li>A key area of focus is to develop strong business relationships via Extraordinary Customer Experience strategy.</li><li>Customer Service Representatives (CSRs) are crucial as they serve as the primary point of contact for both customers and the company.</li><li>They will lead the order-to-cash process, ensuring seamless communication and efficient handling of customer inquiries, orders, and issues.</li><li>Their responsibilities include managing customer interactions, processing orders, addressing concerns, and coordinating with internal teams to ensure timely and accurate delivery of products and services.</li><li>This role is vital in maintaining customer satisfaction and fostering strong, long-term relationships.&nbsp;</li></ul> Responsibilities: <ul><li>Deliver extraordinary customer experience by providing our customer with world class customer service</li><li>Respond promptly to customer inquiries via phone, email.</li><li>Provide detailed information about products, services, and order status.</li><li>Resolve customer complaints and issues efficiently and professionally.</li><li>Process customer orders accurately and efficiently.</li><li>Track order progress and ensure timely delivery.</li><li>Coordinate with planner, logistics, sales, product management and quality teams to fulfill customer</li><li>Serve as the primary point of contact between customers and the manufacturing team.</li><li>Communicate any changes in order status, delays, or issues to customers promptly.</li><li>Prepare and deliver order confirmations, shipping notifications, and other relevant information.</li><li>Maintain accurate and up-to-date customer records and order documentation.</li><li>Generate regular reports on order status, customer interactions, and other relevant metrics.</li><li>Identify trends and provide insights to improve customer service processes.</li><li>Identify and troubleshoot issues related to orders, deliveries, and product quality.</li><li>Gather customer feedback and suggest improvements to products and services.</li><li>Participate in team meetings and training sessions to stay updated on products and processes.</li><li>Assist in the development and implementation of customer agreement and procedures.</li></ul> Requirements: <ul><li>Any Bachelor’s/ Business degrees or equivalent experience.</li><li>Comfortable with Night Shift.</li><li>SAP knowledge.</li><li>Supply chain knowledge.</li><li>SFDC experience (added advantage).</li></ul>

Overview: <ul><li>This position will lead within operations both manufacturing and packaging teams in Somerset, NJ.</li><li>Reporting to one of the operation Managers, operation Supervisors lead teams in designated technology areas and product trains at the site, directs and coordinates the activities of department operators , conduct performance reviews, interact with support departments, and drive efficiencies initiatives within operations.</li><li>The Somerset, NJ site produces oral solid and liquid dosage form pharmaceuticals.</li></ul> Responsibilities: <ul><li>Will lead oral solid dosage form manufacturing and packaging teams as assigned.&nbsp;</li><li>First shift leader with start time 6:00 am to 2:00 pm (8 hr. - 5 days/week) or 5:45 am to 4:00 pm (10 hr, 4 days/week).&nbsp;</li><li>Discussion with Manager on the right fit and team needs.&nbsp;</li><li>Develop, recommend, and implement measures to improve production methods, equipment performance, and quality of product&nbsp;</li><li>Track production processing and material management in SAP&nbsp;</li><li>Daily metrics reporting such as variances in production, labor hours and downtime, track and report operator performance and attendance&nbsp;</li><li>Oversee completion of GPM records and standard operating procedures required within operations&nbsp;</li><li>Participate and develop plans for improving a safe work place and culture of identifying, reporting, and fixing unsafe conditions and behaviors within the site and our work teams.&nbsp;</li><li>Work with cross functional groups to accomplish objectives including finance, procurement, operations, supply chain, maintenance, facilities, technical services, security, quality assurance, and quality control as appropriate.&nbsp;</li><li>Under the direct supervision of a leader and able to communicate progress, needs, requirements, and issues effectively for assigned work for yourself and your teams.&nbsp;</li><li>Carry out all duties in accordance with Good Manufacturing practices (cGMP) and standard operations procedures.&nbsp;</li></ul> Requirements: Qualifications and Education Requirements: <ul><li>Associates degree or higher preferred&nbsp;</li><li>5+ years of pharmaceutical packaging OR manufacturing experience&nbsp;</li><li>2+ years’ experience leading/supervising in a manufacturing environment&nbsp;</li><li>Working knowledge of SAP or another ERP system&nbsp;</li><li>Excellent written communication skills</li></ul>

Job Description: <ul><li>We are seeking a highly motivated Scheduling &amp; Production Planning Analyst with expertise in inventory management and advanced Excel modeling skills.</li><li>The ideal candidate will have 2-3 years of experience in scheduling, production planning, and inventory management, with a strong ability to leverage Excel to optimize processes and improve efficiency.</li><li>A background in finance is an added advantage, helping to drive decisions on new business opportunities, cost analysis and budget management within production and inventory functions.</li><li>In this role, you will be responsible for developing and managing production schedules, optimizing inventory levels, forecasting demand, and analyzing data to support decision-making.&nbsp;</li><li>Your advanced Excel skills will be crucial in creating models for production, inventory planning, and reporting, while your understanding of finance will help identify cost-optimization opportunities.</li></ul> Responsibilities: Production Scheduling &amp; Planning: <ul><li>Develop and manage production schedules, ensuring efficient resource allocation (labor, equipment, raw materials) and meeting production deadlines. Work closely with cross-functional teams to align production goals with business objectives.</li></ul> Inventory Management: <ul><li>Monitor inventory levels and ensure alignment with production schedules.&nbsp;</li><li>Optimize inventory to minimize holding costs and reduce the risk of stockouts or overstock situations.</li></ul> <ul><li>Advanced Excel Modeling: </li></ul> <ul><li>Utilize advanced Excel skills to build and maintain models for production planning, inventory optimization, and scheduling. </li><li>This includes using pivot tables, complex formulas, forecasting, data visualization, and macros to enhance decision-making and operational efficiency.</li></ul> Forecasting &amp; Demand Planning: <ul><li>Work with sales, procurement, and other teams to develop accurate demand forecasts, ensuring production schedules are aligned with customer needs and market trends.</li></ul> Capacity &amp; Resource Planning: <ul><li>Analyze production capacity and resource availability, adjusting schedules and inventory management to meet changing demands and operational constraints.</li></ul> Cost Management &amp; Financial Analysis: <ul><li>Collaborate with finance teams to monitor production and inventory costs, identify inefficiencies, and help with cost optimization strategies.&nbsp;finance background will assist in budgeting and forecasting for production-related topics.</li></ul> Performance Reporting: <ul><li>Prepare and present regular reports on production performance, inventory levels, and key performance indicators (KPIs). Provide data-driven insights and recommendations to improve efficiency, reduce costs, and meet business goals.</li></ul> Process Optimization: <ul><li>Continuously assess and refine production planning, scheduling, and inventory management processes. Recommend and implement improvements to reduce waste, increase throughput, and optimize resource utilization.</li></ul> ERP System Utilization: <ul><li>Use ERP systems (SAP) to manage production and inventory data, ensuring accurate tracking of orders, materials, and resources.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain management, Operations, Business, Finance, or a related field.</li><li>2-3 years of experience in scheduling, production planning, and inventory management.</li><li>Advanced proficiency in Microsoft Excel, including pivot tables, VLOOKUP, advanced formulas, forecasting models, macros, and data analysis.</li><li>Strong understanding of production scheduling, inventory management, and supply chain processes.</li><li>A background in finance or financial analysis is an added advantage, helping to identify cost-optimization opportunities and manage budgets effectively.</li><li>Familiarity with ERP systems (e.g., SAP) and other inventory management tools.</li><li>Strong analytical skills and the ability to interpret complex data and generate actionable insights.</li><li>Excellent communication and collaboration skills, with the ability to work cross-functionally with teams across the organization.</li><li>Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.</li></ul> Preferred Qualifications: <ul><li>Certification in Supply Chain Management or Finance-related qualifications (e.g., MBA) is a plus.</li><li>Experience with data visualization tools (e.g., Power BI, Tableau) for reporting and dashboard creation.</li><li>Knowledge of production planning software or inventory management systems is beneficial.</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

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129 electrical equipment Jobs found

Payroll Analyst

Staff Software Engineer

Customer Quality Engineer

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Representative - SAP

Operation Supervisor

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

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129 electrical equipment Jobs found

Payroll Analyst

Staff Software Engineer

Customer Quality Engineer

Team Lead - Global Trade Compliance

Customer Service Manager

Customer Service Representative - SAP

Operation Supervisor

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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